MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-11-21 for DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH 158R manufactured by Conmed Corporation.
| Report Number | 9353860 |
| MDR Report Key | 9353860 |
| Date Received | 2019-11-21 |
| Date of Report | 2019-10-18 |
| Date of Event | 2019-09-21 |
| Report Date | 2019-10-28 |
| Date Reported to FDA | 2019-10-28 |
| Date Reported to Mfgr | 2019-11-21 |
| Date Added to Maude | 2019-11-21 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DISPOSABLE GASTROINTESTINAL CYTOLOGY BRUSH |
| Generic Name | ENDOSCOPIC CYTOLOGY BRUSH |
| Product Code | FDX |
| Date Received | 2019-11-21 |
| Returned To Mfg | 2019-10-28 |
| Model Number | 158R |
| Catalog Number | 158R |
| Lot Number | 201805314 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 1 DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Manufacturer Address | 525 FRENCH ROAD UTICA NY 13502 US 13502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-11-21 |